Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections

• Sponsor: Calibra Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01073566
• Collaborator: Nancy Bohannon, MD, Med. Corp. (Other), Henry Ford Health System (Other), Northwestern University (Other), University of Texas Southwestern Medical Center (Other), International Diabetes Center at Park Nicollet (Other)
• Enrollment: 38
• Locations: 5
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site: 7.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: Finesse; Device: Pen/Syringe (Usual injection device)	Phase 2

Detailed Description

The aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin using their current pen/syringe.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effects of Finesse on Glycemic Control in Adults With Diabetes Using MDI: Finesse vs. Pen or Syringe and Vial as Bolus Prandial Insulin Device
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Finesse Finesse Insulin Delivery Patch	Device: Finesse; Finesse Insulin Delivery Patch; Other Names: Insulin Bolus Patch
Active Comparator: Usual injection device Pen/Syringe	Device: Pen/Syringe (Usual injection device); Pen/Syringe; Other Names: Insulin pen Insulin syringe Insulin injection device

Outcome Measures

Primary Outcome Measures

1. Mean Daily Blood Glucose [6 weeks]

   Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose

Secondary Outcome Measures

1. Glucose Profiles Per Day [6 weeks]

   Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days

2. Insulin Delivery System Rating [6 weeks]

   Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.

3. Self-reported Hypoglycemic Episodes [6 weeks]

   Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diabetes mellitus on intensive insulin therapy

Exclusion Criteria:

• Insulin pump therapy

• Current use of NPH or regular insulin

• Severe hypoglycemic episodes in prior 6 months

• Unstable cardiac disease, hepatic, or renal function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Pacific Medical Center	San Francisco	California	United States	94110
2	Northwestern University	Chicago	Illinois	United States	60611
3	Henry Ford Health System	Detroit	Michigan	United States	48202
4	International Diabetes Center at Park Nicollet	Minneapolis	Minnesota	United States	55416
5	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Calibra Medical, Inc.
• Nancy Bohannon, MD, Med. Corp.
• Henry Ford Health System
• Northwestern University
• University of Texas Southwestern Medical Center
• International Diabetes Center at Park Nicollet

Investigators

• Study Director: Vice President Clinical Affairs, Calibra Medical, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Calibra Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01073566
• Other Study ID Numbers: VP-00007
• First Posted: Feb 23, 2010
• Last Update Posted: Apr 9, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Calibra Medical, Inc.: Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Immune System Diseases; Insulin; Metabolic Diseases
• Additional relevant MeSH terms: Diabetes Mellitus; Insulin; Insulin, Globin Zinc

Study Results

Participant Flow

Arm/Group Title	Finesse Then Usual Injection Device	Usual Injection Device Then Finesse
Arm/Group Description	Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks	Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
Period Title: Period 1 (6 Weeks)
STARTED	19	19
COMPLETED	19	19
NOT COMPLETED	0	0
Period Title: Period 1 (6 Weeks)
STARTED	19	19
COMPLETED	18	19
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Finesse Then Usual Injection Device	Usual Injection Device Then Finesse	Total
Arm/Group Description	Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks	Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks	Total of all reporting groups
Overall Participants	19	19	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 78.9%	16 84.2%	31 81.6%
>=65 years	4 21.1%	3 15.8%	7 18.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.8 (15.5)	44.9 (15.3)	47.3 (15.4)
Sex: Female, Male (Count of Participants)
Female	8 42.1%	5 26.3%	13 34.2%
Male	11 57.9%	14 73.7%	25 65.8%
Region of Enrollment (participants) [Number]
United States	19 100%	19 100%	38 100%

Outcome Measures

1. Primary Outcome

Title	Mean Daily Blood Glucose
Description	Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Finesse	Usual Injection Device
Arm/Group Description	Bolus Patch	Pen/Syringe
Measure Participants	38	38
Least Squares Mean (Standard Error) [mmol/L]	8.61 (0.28)	9.02 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Finesse, Usual Injection Device
	Comments	A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.
Statistical Test of Hypothesis	p-Value	0.098
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -0.97 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments	Finesse versus usual injection device.

2. Secondary Outcome

Title	Glucose Profiles Per Day
Description	Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Finesse	Usual Injection Device
Arm/Group Description	Bolus Patch	Pen/Syringe
Measure Participants	38	38
Least Squares Mean (Standard Error) [mmol/L]	3.18 (0.18)	3.63 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Finesse, Usual Injection Device
	Comments	This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.80 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments	Finesse versus usual injection device

3. Secondary Outcome

Title	Insulin Delivery System Rating
Description	Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Finesse	Usual Injection Device
Arm/Group Description	Bolus Patch	Pen/Syringe
Measure Participants	38	37
Mean (Standard Deviation) [units on a scale]	82.9 (14.5)	54.9 (17.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Finesse, Usual Injection Device
	Comments	Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	McNemar
	Comments

4. Secondary Outcome

Title	Self-reported Hypoglycemic Episodes
Description	Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Finesse	Usual Injection Device
Arm/Group Description	Bolus Patch	Pen/Syringe
Measure Participants	38	38
Number [episodes]	0	0

Adverse Events

Arm/Group Title	Finesse		Usual Injection Device
Arm/Group Description	Bolus Patch		Pen/Syringe
All Cause Mortality
	Finesse		Usual Injection Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Finesse		Usual Injection Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/38 (2.6%)		1/38 (2.6%)
Gastrointestinal disorders
Acute Pancreatitis	0/38 (0%)	0	1/38 (2.6%)	1
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis	1/38 (2.6%)	1	0/38 (0%)	0
Other (Not Including Serious) Adverse Events
	Finesse		Usual Injection Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/38 (21.1%)		9/38 (23.7%)
Gastrointestinal disorders
Gastroenteritis eosinophilic	1/38 (2.6%)	1	0/37 (0%)	0
Tooth ache	0/38 (0%)	0	1/37 (2.7%)	1
Tooth disorder	0/38 (0%)	0	2/37 (5.4%)	2
General disorders
Medical device site reaction	1/38 (2.6%)	1	0/37 (0%)	0
Infections and infestations
Acute pyelonephritis	1/38 (2.6%)	1	0/37 (0%)	0
Flu	1/38 (2.6%)	1	0/37 (0%)	0
Pharyngitis	0/38 (0%)	0	1/37 (2.7%)	1
Upper respiratory infection	0/38 (0%)	0	4/37 (10.8%)	4
Urinary tract infection	1/38 (2.6%)	1	0/37 (0%)	0
Musculoskeletal and connective tissue disorders
Knee pain	1/38 (2.6%)	1	0/37 (0%)	0
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	0/38 (0%)	0	1/37 (2.7%)	1
Cough	1/38 (2.6%)	1	0/37 (0%)	0
Postnasal drip	1/38 (2.6%)	1	0/37 (0%)	0
Respiratory disorder	1/38 (2.6%)	1	0/37 (0%)	0
Respiratory tract congestion	1/38 (2.6%)	1	0/37 (0%)	0

Limitations/Caveats

The short duration of the study precludes comments on longer-term outcomes.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.